Kornimate/medical-research-clean huggingface dataset:
a phase i, multicenter, open-label, multi-part, dose-escalation study of rad1901 in postmenopausal women with advanced estrogen receptor positive and her2-negative breast cancer

Conditions: Advanced ER+, HER2-Negative Breast Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (rad1901) in patients with advanced er+, her2-negative breast cancer.

the primary objective is to determine the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) of elacestrant in patients with advanced er+her2-negative breast cancer. the secondary objectives of this study are: * to assess the safety and tolerability of elacestrant * to evaluate the pharmacokinetics (pk) of elacestrant * to evaluate the preliminary anti-tumor effect of elacestrant

Eligibility criteria:
key inclusion criteria: 1. patients must be post-menopausal women, as defined in the protocol 2. 18 years or older 3. patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease 4. part a, b, c: patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy 5. part d: patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. patients must have received prior treatment with a cdk4/6 inhibitor note: this list is not complete. further inclusion criteria is provided in the protocol synopsis. key exclusion criteria: 1. prior anticancer or investigational drug treatment within the following windows: 1. tamoxifen therapy less than 14 days before first dose of study treatment 2. part a, b and c: fulvestrant therapy less than 90 days before first dose of study treatment. part d: fulvestrant therapy less than 42 days before first dose of study treatment 3. any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment 4. any chemotherapy less than 28 days before first dose of study 5. any investigational drug therapy less than 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment 2. patients with untreated or symptomatic central nervous system (cns) metastases 3. patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts note: this list is not complete. further exclusion criteria is provided in the protocol synopsis.
prevention and treatment of perioperative lung injury in elderly patients

Conditions: Postoperative Pulmonary Complications; Elderly Patients

Summary: this study aims to verify the prediction model of postoperative pulmonary complications by collecting clinical information on elderly patients. in addition, the incidence of postoperative pulmonary complications in elderly patients before and after using the prediction model was compared.

more than 300 million major operations are performed worldwide each year, and older patients account for about a third of elective operations. compared with young people, the elderly are more prone to postoperative complications due to age-related degeneration of the physiological functions of various organs and tissues. postoperative pulmonary complications, including pneumonia, atelectasis, and respiratory failure, are common. even mild pulmonary complications can lead to the prolonged hospital stay and increased postoperative mortality. although there have been many studies on postoperative lung complications, there have been few studies on elderly patients. in our country, the real incidence data of elderly patients after a perioperative period of pulmonary complications, the lack of effective prevention, intervention measures, and targeted prevention and treatment technology, these reasons lead to the clinical diagnosis and treatment of elderly patients after a perioperative period of pulmonary complications are very difficult. therefore, the research team intends to verify the established prediction model of postoperative pulmonary complications and compare the incidence of postoperative pulmonary complications in elderly patients before and after using the prediction model.

Eligibility criteria:
inclusion criteria: 1. age 65 years or older 2. receiving invasive ventilation during general anesthesia for surgery exclusion criteria: 1. preoperative mechanical ventilation 2. procedures related to a previous surgical complication 3. a second operation after surgery within one week 4. organ transplantation 5. discharged within 24 hours after surgery
pneumococcal vaccines early and in combination

Conditions: Otitis Media

Summary: the purpose of this study is to determine whether an early schedule of a combination of three doses of phid-cv and one dose of pcv13, is superior to three doses of either pcv13 or phid-cv.

aboriginal children in the northern territory (nt) have high rates of otitis media caused by non-capsular h. influenzae (nchi) and pneumococci. pneumococcal conjugate vaccine has effectively reduced disease caused by the 7 serotypes. rates of non-vaccine serotype otitis media (om), particularly 19a is increasing, and nchi continues to be a major pathogen in perforations. parallels with pneumonia are highly probable in this population. vaccines with expanded and early age protection are needed. in early 2009 gsk's pneumococcal h. influenzae protein d conjugate vaccine (phid-cv) was licensed in australia. compared to the current vaccine, 7pcv, this vaccine offers protection from pneumococcal serotypes 1, 5, 7f as well as nchi (which is a primary pathogen of om, and possibly pneumonia). however by 2010, a new generation of wyeth's 7pcv, pcv13 will also be licensed in australia. compared to phid-cv this vaccine offers protection from additional serotypes 3, 6a and 19a, however it does not offer protection from nchi infection. there is no empirical evidence to suggest that either vaccine will have superior clinical efficacy for otitis media or pneumonia in high-risk children. the novel combination strategy proposed for this trial has the potential to provide the best of both vaccines.

Eligibility criteria:
inclusion criteria: indigenous infants * 4 to 6 weeks of age * living in remote communities that have provided signed expressions of interest in participating in prev-ix_combo trial * intend to remain in their community until their baby is 7 months of age * eligible for routine vaccinations. exclusion criteria: * prior adverse reaction to pneumococcal conjugate vaccines according to australian immunization handbook. * gestational age \< 32 weeks

Keywords: otitis media pneumococcal vaccines randomised controlled trial high-risk children indigenous australia
clinical safety and preliminary efficacy of muc1-dc-ctl treatment in stage iv gastric cancer.

Conditions: Gastric Cancer

Summary: in this study, safety and effects of muc1-gene-dc-ctl and muc1-peptide-dc-ctl on human gastric cancer are going to be investigated.

pbmc of the patient will be separated from peripheral blood.dcs infected by muc1 and pulsed by muc-1 peptide are made respectively from pbmc, then they are respectively cultured with t cells into muc1-gene-dc-ctl and muc1-peptide-dc-ctl which will be infused to the patients as immunotherapy.

Eligibility criteria:
inclusion criteria: * sex: male or female * age: from 18 to 80 years * histology: gastric cancer * clinical stage: stage iv * karnofsky performance status: more than 50% * expected survival: more than 2 months * laboratory tests results 7 days before the start of treatment: * white blood cells: more than 3.0 × 109/l * platelets: more than 100 × 109/l * neutrophils: more than 1.5 × 109/l * hemoglobin: more than 80g/l * serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (uln) * serum glutamic-oxal (o) acetic transaminase: less than 2.5 × uln * serum bilirubin: less than 1.25 × uln * serum creatinine: less than 1.25 × uln * pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment * contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study * informed consent: subject must have the ability to understand and voluntarily sign a written informed consent exclusion criteria: * history of neoplasms: other neoplasms * medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy * metastasis: clinical symptoms of brain metastasis * other clinical trial: the subject received other clinical trial before this study * laboratory tests: the serum test of human immunodeficiency virus, or hepatitis b virus, or hepatitis c virus was positive * woman: pregnant or lactating women * compliance: poor compliance
evaluation of truebeam for low-intermediate risk prostate cancer

Conditions: Prostate Neoplasms

Summary: the primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after truebeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. the primary efficacy purpose is to compare 5 year biochemical disease free survival rates with truebeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.

the prescribed ptv dose of 36.25gy shall be given in 5 fractions using the truebeam stx. at one week after treatment, toxicity and aua score will be evaluated. at 1 month following treatment, patients will be assessed for acute toxicity, and will fill out aua form, sf-12, epic-26, shim and utilization of sexual rx/devices. at 3, 6, 12, 18, and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), patients will be seen and evaluated, including a history, physical exam, ecog performance status, psa, toxicity evaluation, and aua score. in addition, at 6 months, 12 months and annually thereafter, the sf-12, epic-26, shim and utilization of sexual medications/devices will be administered. examination and studies may be done at outside facility. a prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure.

Eligibility criteria:
inclusion criteria: * histologically proven prostate adenocarcinoma within 1 year of enrollment * low risk: gleason \<or=6 \& psa \<or=10 \& clinical stage t1b-t2a,nx or n0, mx or m0 * intermediate risk:gleason \ 10 \& \< or =20 \& clinical stage t1b- t2b, nx or no, mx or m0 * ecog performance status 0-1 * no prior prostate radiation or other definitive therapy exclusion criteria: * implanted hardware or other material that would prohibit treatment planning or delivery * chemotherapy for a malignancy within the previous 5 years * history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years * hormone ablation for 2 months prior to treatment or during treatment

Keywords: low risk prostate cancer intermediate risk prostate cancer stereotactic radiosurgery
selepressin evaluation programme for sepsis-induced shock - adaptive clinical trial

Conditions: Septic Shock

Summary: this is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. the trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * proven or suspected infection * septic shock defined as hypotension requiring vasopressor treatment despite adequate fluid resuscitation * informed consent obtained in accordance with local regulations exclusion criteria: * not possible to initiate trial drug treatment within 12 hours from onset of vasopressor treatment for septic shock * primary cause of hypotension not due to sepsis * previous severe sepsis with intensive care unit admission within this hospital stay * known/suspected acute mesenteric ischaemia * suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ecg during this episode of septic shock * chronic mechanical ventilation for any reason or severe chronic obstructive pulmonary disease (copd) requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of copd) during the preceding 30 days * received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia * known to be pregnant * decision to limit full care taken before obtaining informed consent * use of vasopressin in the past 12 hours prior to start of trial drug treatment or use of terlipressin within 7 days prior to start of trial drug treatment * prior enrolment in the trial * prior use of an investigational medicinal product within the last month or planned or concurrent participation in a clinical trial for any investigational drug or investigational device
outcomes and user acceptance of the intellivue alarm advisor software (usa)

Conditions: Clinical Alarms

Summary: this clinical study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post- implementation of an "alarm advisor software".

in a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded. in an interim period an alarm advisor software will be introduced to the unit. in a second phase (post-implementation) the same set of alarm data will be recorded. the "alarm advisor" software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits). the effect of reduction of recurring nuisance alarms through the implementation of the alarm advisor shall be evaluated.

Eligibility criteria:
inclusion criteria: - patients admitted to the intensive care units during the study periods exclusion criteria: - none

Keywords: alarms alarm fatigue alarm nuisance alarm reduction patient monitoring intensive care
post-authorisation study on the use of bemfola® in human assisted reproductive technology

Conditions: Infertility

Summary: prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hfsh product (bemfola®) for ovarian stimulation and gnrh-antagonists for pituitary suppression

this will be a prospective, non-comparative, multi-centre, multi-country, observational post-authorization study in germany and austria. the study will evaluate the use of follitropin alfa (bemfola®) in controlled ovarian stimulation for ivf/icsi. about 30 art centres will be involved in the study. upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria. as this is an observational study, there will be no additional treatment or diagnostic procedures performed on subjects other than those of the investigators' local routine clinical practice. the decision to start art treatment and to use bemfola® in controlled ovarian hyperstimulation (coh) following a gnrh antagonist protocol will be made independently by the investigators as per the art centre's protocol, preceding patient enrollment for this study.

Eligibility criteria:
inclusion criteria: * female subject justifying an ivf/icsi treatment * age over 18 years (inclusive) at the time of the screening visit * signed informed patient consent * received only bemfola® for ovarian stimulation * pituitary suppression with gnrh-antagonists exclusion criteria: * hypersensitivity to the active substance follitropin alfa, fsh or to any of the excipients * tumours of the hypothalamus or pituitary gland * ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome * gynaecological haemorrhages of unknown aetiology * ovarian, uterine or mammary carcinoma

Keywords: bemfola r-hfsh oocytes pregnancy ohss
using skin blood flow to measure the effect of different doses of negative pressure therapy

Conditions: Hypertrophic Scars

Summary: introduction. skin blood flow (sbf) is crucial for transporting nutrients during healing to treat scarring. negative pressure therapy (npt) is a promising option to enhance sbf. however, it is unclear what dosage of npt is most effective in treating scars. this study compared npt dosages of -105 mmhg, -125 mmhg, and -145 mmhg to assess the impact of npt treatment on sbf in scar tissue and the correlation of npt. if participants experience any symptoms of discomfort, npt can be discontinued immediately. 36 scarred subjects were recruited to assess the efficacy of various npt interventions. sbf applications are defined as perfusion levels instantly affecting npt, and termination is defined as sbf after npt. the study runs from may 11, 2022, to may 11, 2023, at asia university hospital. this study was funded by the national science and technology council, taiwan (nstc 112-2221-e-468-004) the main contact was chi-wen lung, the person in charge of a college or university department of product design, asia university, taichung 413305, taiwan.email address: cwlung@asia.edu.tw

introduction. skin blood flow (sbf) is crucial for transporting nutrients during healing to treat scarring. negative pressure therapy (npt) is a promising option to enhance sbf. this study's hypothesis was that npt can enhance sbf in scar tissue and that the specific npt dose affects this effect. the purpose of this study was to confirm the different dosages of npt applied to scar tissue by comparing the blood flow before and after the effects of different npt dosages. this will also contribute to the emerging field of scar treatment and provide evidence-based recommendations. all recruited participants were approached to participate in a research study investigating the effects of npt in a double-blind, parallel-group study on scar healing. this study used three negative pressure changes at -105, -125 mmhg, and -145 mmhg at 10 min. the suction method created a negative pressure in the cup using an electronic negative-pressure device (medi pump tc-2000v; anest iwata sparmax co., ltd., taipei, taiwan). a cup with an inner diameter of 45 mm and outer diameter of 53 mm was used for cupping therapy. each side of the cup rim had a width of 4 mm; therefore, no pain was caused by the cup rim. pearson product-moment correlation analysis was used to determine the correlations between the sbf-baseline, sbf-application, and sbf-termination factors.

Eligibility criteria:
inclusion criteria: * aged 18 years or older. * wounds must have been present for at least 21 days. * the participants were in the proliferation or remodeling phase. * within nine months of skin injury. exclusion criteria: * incomplete wound healing. * leakage of tissue fluid. * participants of the edema. * the other short-term treatment plans (pressure garments, radiotherapy, steroids, and cryotherapy).

Keywords: scar laser doppler tensile stresses capillaries cupping
adapting an advocacy services intervention for latinx families of transition-aged youth with autism spectrum disorder

Conditions: Autism

Summary: when youth with autism spectrum disorder (asd) transition from school to adult services, they fall off a "service cliff." to increase access to services, the investigators developed the assist program, which teaches parents how to advocate for adult services on behalf of youth with asd. in a pilot randomized controlled trial (rct: r34 mh104428), treatment group (versus control) participants demonstrated significantly improved knowledge of adult services, advocacy, and empowerment. sons/daughters of treatment group participants had increased access to services. for advocacy services interventions like assist to be equitable, they need to reach families who are at greatest risk for service disparities. latinx youth with asd are one such underserved population. relative to white youth, latinx youth with asd receive significantly fewer post-secondary education, health, and employment services and face worse post-school outcomes. in addition to the barriers which hinder service access for all families, latinx families face unique barriers to service access (e.g., language, cultural differences, citizenship, discrimination) making them a marginalized population. in this project, the investigators are adapting the assist curriculum and related measures for latinx parents of transition-aged youth with asd. specifically, the investigators will leverage assist data and data from latinx, non-assist parents to inform adaptations to the assist curriculum. the investigators will also conduct pre-testing and a cross-cultural adaptation process to revise the assist measures for latinx families. the investigators will test the adapted assist curriculum with a randomized controlled trial to determine its feasibility, acceptability and efficacy on intervention targets (knowledge, advocacy, and empowerment) and outcome of interest (service access). this project is aligned with nimh priorities by examining services from adolescence to adulthood (pa-21-199) and by adapting a program to improve mental health services for underserved populations nimh 2020 strategic plan). it is also responsive to the interagency autism coordinating committee core value of "equity" in reducing disparities with respect to cultural backgrounds. further, if successful, it will be the first intervention to directly address service disparities for latinx families of youth with asd who are transitioning to adulthood.


Eligibility criteria:
inclusion criteria: to be included in the study, the participant must be: * over the age of 18, * identify as latinx, * have a child with autism who is over the age of 12, * speak spanish, and * reside in illinois. exclusion criteria: * must understand spanish